(25 days)
No
The description details a quantitative biochemical assay based on enzymatic reactions and spectrophotometry, with no mention of AI or ML techniques for data analysis or interpretation.
No
The device is described as being for "quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma." It is an in-vitro diagnostic test, not a therapeutic device.
Yes
This device is intended for the quantitative determination of antithrombin in human citrated plasma, which is a measurement used in diagnosis. The "Intended Use / Indications for Use" section explicitly states its purpose for quantitative determination in human plasma.
No
The device description explicitly states that "All components of the kit are in liquid formulation (LR = Liquid Reagents)," indicating it is a reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma." This indicates that the device is used to perform a test on a biological sample (human plasma) outside of the body (in vitro) to obtain diagnostic information (quantitative determination of AT activity).
- Device Description: The "Device Description" reiterates the intended use and describes the components and the method used to perform the test, which involves chemical reactions with the plasma sample.
- Performance Studies: The inclusion of "Summary of Performance Studies" detailing method comparison and precision data is typical for IVD devices, as regulatory bodies require evidence of performance for diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" (K994238 IL Test™ Liquid Antithrombin) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).
Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.
Product codes
JBQ, JBO
Device Description
Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).
Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Method Comparison: In a method comparison study evaluating 61 citrated plasma samples with Antithrombin levels ranging in value from 8.6% to 121.5% AT activity, the correlation statistics for Coamatic® LR Antithrombin on an ACL Futura versus the predicate device on an ACL 9000 are shown below:
System: ACL Futura, Slope: 1.011, Intercept: 0.4889, r: 0.995, Reference Method: IL TestTM Liquid AT on ACL 9000
Precision: Within run and total precision assessed over multiple runs using three levels of control plasma gave the following results:
ACL Futura:
Mean (% AT): 114, CV% (Within run): 1.96, n: 6, CV% (Total): 3.52, n: 60
Mean (% AT): 59, CV% (Within run): 6.21, n: 6, CV% (Total): 6.43, n: 60
Mean (% AT): 29, CV% (Within run): 8.45, n: 6, CV% (Total): 11.09, n: 60
Key Metrics
Method Comparison: r = 0.995
Precision:
CV% (Within run): 1.96% (at 114% AT), 6.21% (at 59% AT), 8.45% (at 29% AT)
CV% (Total): 3.52% (at 114% AT), 6.43% (at 59% AT), 11.09% (at 29% AT)
Predicate Device(s)
K994238 IL Test™ Liquid Antithrombin
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).
0
AUG 2 7 2002
IC022552
Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207
Contact Person:
Carol Marble, Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
August 1, 2002
Name of the Device:
Coamatic® LR Antithrombin
Classification Name(s):
| 864.7060 | Antithrombin III Assay | Class II |
|---|---|---|
| 81JBQ | Antithrombin III Quantitation |
Identification of Predicate Device(s):
K994238 IL Test™ Liquid Antithrombin
Description of the Device/Intended use(s):
Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).
Antithrombin is the most important natural inhibitor of the coagulation cascade. Bv inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
Coamatic® LR Antithrombin is substantially equivalent in performance to the predicate device: IL Test™ Liquid Antithrombin
1
Section 3 Coamatic® LR Antithrombin - 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In a method comparison study evaluating 61 citrated plasma samples with Antithrombin levels ranging in value from 8.6% to 121.5% AT activity, the correlation statistics for Coamatic® LR Antithrombin on an ACL Futura versus the predicate device on an ACL 9000 are shown below:
| System | Slope | Intercept | r | Reference Method |
|---|---|---|---|---|
| ACL Futura | 1.011 | 0.4889 | 0.995 | IL TestTM Liquid AT on ACL 9000 |
Precision
Within run and total precision assessed over multiple runs using three levels of control plasma gave the following results:
| ACL Futura | |||||
|---|---|---|---|---|---|
| Mean (% AT) | CV% (Within run) | n | CV% (Total) | n | |
| 114 | 1.96 | 6 | 3.52 | 60 | |
| 59 | 6.21 | 6 | 6.43 | 60 | |
| 29 | 8.45 | 6 | 11.09 | 60 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 098 Gaither Road Rockville MD 20850
AUG 2 7 2002
Ms. Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02421-3125
K022550 Re: Trade/Device Name: Coamatic® LR Antithrombin Regulation Number: 21 CFR § 864.7060 Regulation Name: Antithrombin III Assay Regulatory Class: II Product Code: JBO Dated: August 1, 2002 Received: August 2, 2002
Dear Ms. Marble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Coamatic® LR Antithrombin
Indications for Use:
Coamatic® LR Antithrombin is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma. All components of the kit are in liquid formulation (LR = Liquid Reagents).
Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 15-125% of normal plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign/Off) | |
|---|---|
| Division of Clinical Laboratory Devices | K022550 |
| 510(k) Number |
Prescription Use __________ OR Over-The-Counter Use __________
(Per 21 CFR 801.019)
Coamatic® LR Antithrombin 510(k)